Histomorphometric results of a randomized controlled clinical trial studying maxillary sinus augmentation with two different biomaterials and simultaneous implant placement

Purpose: Maxillary sinus augmentation has been a predictable procedure. However, in-depth analysis of tissue healing after sinus grafting with simultaneous implant placement is limited. This study aimed to compare histologic outcomes after sinus grafting with a synthetic bone graft compared with a xenograft. Materials and Methods: A randomized controlled split-mouth study was conducted to compare bone formation around microimplants (2.00 mm, Dentium) placed at the time of maxillary sinus augmentation with a synthetic material (Osteon, Dentium) (OST) and deproteinized bovine bone (Bio-Oss) (BIO) as the control group. Four microimplants per subject (n = 13) were placed bilaterally for intrasubject comparison (two implants per side/patient). Bone cores with osseointegrated microimplants were harvested for histomorphometric analysis 6 to 8 months after sinus augmentation surgery. Results: Histologic analysis revealed newly formed bone deposited on the microimplant surface and bridging to bone graft material in both groups. Further, there was no histologic evidence of signs of inflammation in all specimens. In general, bone-to-implant contact was comparable and ranged from 6.1% to 67.0% with a mean of 38.4% ± 11.61% in OST and from 10.5% to 57.0% with a mean of 34.58% ± 12.55% in BIO. However, a significantly higher percentage of bone-to-implant contact in the first four threads of the grafted area was noted in OST compared with BIO (P = .016). Conclusion: The synthetic OST was found to be equivalent to BIO in new bone formation and clinical success after sinus augmentation in conjunction with microimplant placement. Although there are some statistically significant differences in the histologic outcomes, the clinical relevance of these needs to be further evaluated. Nevertheless, the findings of this study indicate that this synthetic alloplast would be a viable alternative to an allograft material.